More Trouble at Idenix Pharmaceuticals (IDIX)
Idenix Pharmaceuticals (NASDAQ:IDIX) turned in poor earnings and released more bad news at the same time.
For the third quarter ended September 30, 2009, Idenix reported total revenues of $3.1 million, compared to total revenues of $2.1 million in the third quarter of 2008. Idenix reported a net loss of $11.7 million, or a loss of $0.18 per basic and diluted share, for the third quarter ended September 30, 2009, compared to a net loss of $16.9 million, or a loss of $0.30 per basic and diluted share for the third quarter ended September 30, 2008.
The company said it had cash to carry though the next 12 months, not a comforting thought.
IDIX also announced that Novartis Pharma AG has decided not to exercise its option to license IDX184, a novel liver-targeted prodrug of 2′-methyl guanosine nucleotide, for the treatment of HCV. As a result, Idenix retains the worldwide rights to develop, commercialize and license IDX184 without any further obligation to Novartis.
Shares are off 15% to $2.13 down from a 52-week high of $6.82.
Douglas A. McIntyre
Working the Human Genome Sciences Magic (HGSI)
Human Genome Sciences, Inc. (NASDAQ: HGSI) has been soaring today and the stock hit new 52-week highs. As of 2:45 PM EST we Human Genome Sciences had already crossed a full day’s trading volume at 120% normal stock trading volume. The culprit for today’s significant strength s of course the JPMorgan upgrade to Overweight from Neutral. But the catalyst for the upgrade is ahead of new additional clinical data being presented on its Benlysta experimental lupus drug next week.
We also noted how and that options were picking up throughout the day. Our friend over at OptionsHawk.com just sent us more details on the options trading:
Human Genome (HGSI) is trading 84,000 calls and 21,000 puts on the day after an upgrade at JP Morgan before the key November 2nd Benlysta second of two Phase 3 trial data for the treatment of Lupus, which would make it the leading contender in the market for a highly lucrative potential market. Smart money has been bullish the name in recent weeks with 10,000 contract November $25/$30 call spreads and various other strategies as the common consensus is a 70% chance of the drug having a positive outcome. Despite implied volatility being at 193%, many are still betting on volatility expecting a sharper than priced in reaction. Today’s action represents 4X the average call volume, although only 1/4th of the action is offer side buying, but ISE Sentiment indicates 3 calls are being opened for every 1 put. One of the larger trades today is slightly bullish but bearish on volatility as the trader used a butterfly call spread, buying 3,500 of the November $20 and $30 calls, and selling 7,000 of the $25 calls, expecting shares to trade around the $25 level and for Implied Volatility to be crushed. -OptionsHawk.com
The reason that Human Genome is such a battleground stock is because the lupus drug is a new entrant in an old field that has had very limited new development in years. This also has blockbuster drug written all over it if it approved. The October 15 settlement date for short interest has the short interest listed as 17,967,328 shares. That is actually the fifth consecutive short interest drop, meaning that traders are lightening up on trying to bet against the stock since at least mid-August.
With an hour left for trading, Human Genome Sciences is up almost 14% at $20.49, and that is after hitting an intra-day high (and yearly high) of $20.62.
JON C. OGG
Top Analyst Upgrades-Downgrades in BioHealth Sector (BMRN, CBST, CYTK, ELN, PPDI, RGEN)
This morning we have seen an unusual number of analyst upgrades and downgrades in the drug and biotech space that comprises BioHealth. These are the top analyst upgrades, downgrades, and initiations in the BioHealth sector this Thursday morning:
- BioMarin (NASDAQ: BMRN) Raised to Outperform at Credit Suisse.
- Cubist Pharmaceuticals (NASDAQ: CBST) Raised to Perform at Oppenheimer.
- Cytokinetics (NASDAQ: CYTK) Cut to Hold at Needham.
- Elan Corp. plc (NYSE: ELN) Cut to Neutral at UBS.
- Pharmaceutical Product Development (NASDAQ: PPDI) Cut to Market Perform at Wells Fargo.
- Repligen (NASDAQ: RGEN) Cut to Sector Perform at RBC Capital.
If you like analyst upgrades, downgrades, and initiations, you can join our open email distribution list from 24/7 Wall Street to get updates on top analyst upgrades and downgrades, top day trader alerts, IPO’s, secondary offerings, Warren Buffett and other guru activity, M&A and more.
JON C. OGG
Anika (ANIK) Earnings
Anika Therapeutics (NASDAQ:ANIK) is not much of a company. It has a market cap of $81 million.
Total revenue for the third quarter of 2009 increased 17% to $10,793,000 from $9,205,000 in the third quarter of 2008, a very modest increase.
Net income for the third quarter of 2009 grew 37% to $1,512,000, or $0.13 per diluted share, from $1,104,000, or $0.10 per diluted share, for the same period last year.
The news pusshed ANIK shares higher to 13% to $7.16.
Douglas A. McIntyre
Helicos (HLCS) Picks Up A Little Cash
Helicos BioSciences (NASDAQ:HLCS) picked up a little extra cash. According to an update passed out by the company today, sales of the Helicos Genetic Analysis System more than doubled last quarter.
Helicos expects approximately $5 million in cash receipts from previously announced System orders and associated reagent purchases. Cash inflows from these orders are expected to occur during the fourth quarter of 2009 and the first quarter of 2010.
The firm also confirmed that it raised $9.3 million. It also confirmed that Thomas Weisel Partners was examining “stategic options” for Helicos, which means it is trying to find a buyer.
Shares are up 10% on all of that news to $2.30.
Douglas A. McIntyre
Asthma Test Flop (ICGN)
Icagen, Inc. (NASDAQ: ICGN) was already a low-priced small cap stock. That may only be an even lower market capitalization rate company on Tuesday. The small biotech reported that its Phase IIa exercise-induced asthma study of its Senicapoc failed to demonstrate improvement in the primary study endpoints.
The kiss good-bye: Although the Company will continue to evaluate the data from this trial, it does not anticipate continuing clinical development of senicapoc at this time. After reading that, the rest of the data offered is sort of moot when you consider that it is over for this candidate.
The company said that this included maximum decrease in FEV1, time to recovery of FEV1 after exercise and area under the FEV1 curve for sixty minutes. The double blind placebo-controlled study had 69 randomized patients receiving either senicapoc at a maintenance dose of 40MG per day or receiving the placebo. It noted that “all subjects were tested for pulmonary function following a standardized treadmill exercise regimen at baseline, two and four weeks after treatment. The results of the pulmonary function tests were compared between the treatment groups, adjusting for differences in baseline values.”
Here is the company’s remaining drug pipeline in clinical and pre-clinical programs.
Shares got crushed after the stock was reopened for trading. This closed down 7% at $0.77 and the stock is down over 40% at $0.45 and the 52-week trading range is $0.31 to $1.68. At the end of the June quarter the company had $24.13 million in cash and equivalents and only $5.483 million listed as its total liabilities. The total market cap before tonight’s share price drop was $36.2 million, and the implied 40% haircut would put the market cap around $21.7 million.
Jon C. Ogg
October 26, 2009
BioCryst, Answer for Swine Flu H1N1 Vaccine Shortages? (BCRX)
I have been a pretty upset US citizen so far this Fall ahead of flu season. I cannot find available regular flu shots at any of my go-to spots. Many drug stores in Houston even have the recording on their telephone answering systems that they do not have the seasonal flu vaccines at this time. And as far as the H1N1 or swine flu vaccine, forget about getting easy access to it. BioCryst Pharmaceuticals, Inc. (NASDAQ: BCRX) may be one answer. But the stress here is on ‘may.’
BioCryst Pharmaceuticals, Inc. (NASDAQ: BCRX) is trading higher on H1N1 or swine flu news this morning. The company’s intravenous experimental drug called peramivir received an “emergency use authorization” by the FDA in response to a request from the U.S. Centers for Disease Control and Prevention. The emergency use authorization for peramivir is for certain adult and pediatric patients with confirmed or suspected 2009 H1N1 influenza infection who are admitted to a hospital.
This is good news, except that this is solely for patients admitted into the hospital. By the time most people decide they have to go to the hospital, they are probably already having severe health issues.
BioCryst is likely to see an immediate boost from this. The company generated a mere $56.561 million in 2008 revenues, down from $71.238 million in 2007 revenues. And the revenue estimates from Wall Street are too few to know if they are even legitimate “consensus figures.” But the estimates appear to be $23.71 million for 2009 and $51.29 million for 2010 according to Thomson Reuters.
At 9:45 AM EST we have BioCryst shares trading up 14.7% at $11.08, and we have already seen 150% of its normal average trading volume with over 4.1 million shares having traded hands.
JON C. OGG
OCTOBER 26, 2009
Question About Arena Pharmaceuticals (ARNA)
Arena Pharmaceuticals (NASDAQ:ARNA) announced what should have been viewed as positive news, but its shares barely moved.
The firm reported that reported that data from the pivotal BLOOM (Behavioral modification and Lorcaserin for Overweight and Obesity Management) Phase 3 trial demonstrate lorcaserin significantly increased excess weight loss, improved markers of cardiovascular risk and glycemic parameters, and was not associated with depression or suicidal ideation. Additional subgroup analyses showed that lorcaserin caused the greatest improvements in lipid profiles, glycemic parameters and other markers of cardiovascular risk in patients in the highest risk categories. The new data were presented at Obesity 2009, the 27th Annual Scientific Meeting of The Obesity Society. Read more
PML Side Effect Concerns Moving Beyond MS to RA (RHHBY, BIIB)
PML, or progressive multifocal leukoencephalopathy, is moving beyong TYSABRI as a side effect in the world of drugs and pharmaceuticals. Yesterday the FDA posted a ‘Dear Doctor letter’ from Genentech, now part of Roche (OTC: RHHBY). Unfortunately, this involves Biogen Idec, Inc. (NASDAQ: BIIB) as well. The two companies notified healthcare professionals about a third case of PML, the first case of PML in a patient with rheumatoid arthritis treated with Rituxan who has not previously received treatment with a TNF antagonist.
The companies noted that information to date suggests that patients with RA who receive Rituxan have an increased risk of PML and that doctors should consider PML in any patient being treated with Rituxan who presents with new onset neurologic manifestations.
You can read the full letter and explanations here. Unfortunately, PML risks are likely to come more front and center in the coming weeks and months.
It is worth noting that this is not the first of the potentially fatal side effects of Rituxan. There have been prior warnings of brain disorders and other warnings including cardiac arrest, reactivation of Hepatitis B, kidney failure, and more. And PML is already a noted risk in Rituxan.
It JON C. OGG
More TYSABRI MS Woes, Sort Of (BIIB, ELN, ACOR)
Biogen Idec Inc. (NASDAQ: BIIB) is feeling the pain of regulatory review this morning. And Elan Corp. plc (NYSE: ELN) is feeling it even worse. The reason these are under pressure this Friday is because a European panel has begun a review of Biogen’s controversial yet effect multiple sclerosis drug TYSABRI. The review is over higher rates of PML brain infections (progressive multifocal leukoencephalopathy) than had been disclosed.
The European Medicines Agency’s Committee for Medicinal Products for Human Use showed some 23 PML cases since the launch of TYSABRI. Previous data showed that there were 13 cases since TYSABRI came back on the market in 2006 after the company voluntarily removed it to study the PML data. The European panel will discuss additional measures, if needed, to ensure a safe use of the drug and how to measure risks.
Biogen Idec is already in U.S. talks with the FDA over the TYSABRI label. Most recent data showed more than 46,000 people were taking TYSABRI, and over 13,000 patients had been taking TYSABRI for more than two years and were classified under long-term use.
It is impossible to pre-judge this situation, but personal discussions have given a personal belief here that the reason people keep taking TYSABRI is because many think it is the best MS drug on the market. As far as a 1 in a thousand risk, that is a very low incident ratio compared to other drugs that treat other diseases and many are willing to take that risk.
Biogen Idec is down 5.7% at $44.50 and Elan is down almost 17% at $5.35. Acorda Therapeutics, Inc. (NASDAQ: ACOR) has been noted this week as having an MS drug candidate pending under priority review date and that has been extended out to January 2010 by the FDA.
JON C. OGG
OCTOBER 23, 2009
